fensolvi

Generic: leuprolide acetate

Labeler: tolmar inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fensolvi
Generic Name leuprolide acetate
Labeler tolmar inc.
Dosage Form INJECTION, SUSPENSION, EXTENDED RELEASE
Routes
SUBCUTANEOUS
Active Ingredients

leuprolide acetate 45 mg/.375mL

Manufacturer
TOLMAR Inc.

Identifiers & Regulatory

Product NDC 62935-163
Product ID 62935-163_6ad49800-db23-42bb-8543-1bbb6a9c96f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213150
Listing Expiration 2026-12-31
Marketing Start 2023-03-06

Pharmacologic Class

Classes
gonadotropin releasing hormone receptor agonist [epc] gonadotropin releasing hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62935163
Hyphenated Format 62935-163

Supplemental Identifiers

RxCUI
752884 2371773
UNII
37JNS02E7V

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fensolvi (source: ndc)
Generic Name leuprolide acetate (source: ndc)
Application Number NDA213150 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 45 mg/.375mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (62935-163-60) / .375 mL in 1 SYRINGE
source: ndc

Packages (1)

62935-163-60 1 SYRINGE in 1 CARTON (62935-163-60) / .375 mL in 1 SYRINGE

Ingredients (1)

leuprolide acetate (45 mg/.375mL)

Linked Drug Pages (1)

Fensolvi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "6ad49800-db23-42bb-8543-1bbb6a9c96f2", "openfda": {"unii": ["37JNS02E7V"], "rxcui": ["752884", "2371773"], "spl_set_id": ["2c311700-edf4-4f2a-a468-9875489a6cc7"], "manufacturer_name": ["TOLMAR Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (62935-163-60)  / .375 mL in 1 SYRINGE", "package_ndc": "62935-163-60", "marketing_start_date": "20230306"}], "brand_name": "Fensolvi", "product_id": "62935-163_6ad49800-db23-42bb-8543-1bbb6a9c96f2", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Gonadotropin Releasing Hormone Receptor Agonist [EPC]", "Gonadotropin Releasing Hormone Receptor Agonists [MoA]"], "product_ndc": "62935-163", "generic_name": "Leuprolide Acetate", "labeler_name": "TOLMAR Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fensolvi", "active_ingredients": [{"name": "LEUPROLIDE ACETATE", "strength": "45 mg/.375mL"}], "application_number": "NDA213150", "marketing_category": "NDA", "marketing_start_date": "20230306", "listing_expiration_date": "20261231"}